- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00681187
Somatuline Autogel Preference and Health Economy Study (SAPHE)
A Phase IV, International, Open-label, Randomised, Cross-over Study to Assess Patient Preference and Health Economy in Patients With Neuroendocrine Tumours, Treated With Lanreotide Autogel Given as Self Administration.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University Hospital / Medisinsk afd. V
-
Odense, Denmark, 5000
- Odense Univeristy Hospital / S-AMB
-
-
-
-
-
Bergen, Norway, 5021
- Haukeland University Hospital / Kreftafd
-
Tromsø, Norway, 9038
- University Hospital North-Norway / GastroLab
-
Trondheim, Norway, 7006
- S:t Olavs Hospital / Medisinsk Afd
-
-
-
-
-
Gothenburg, Sweden, 413 45
- Sahlgrenska University Hospital / Kirurgkliniken
-
Linköping, Sweden, 581 85
- Linköping University Hospital / Onkologen
-
Stockholm, Sweden, 141 86
- Karolinska University Hospital, Huddinge / GastroCentrum Medicin
-
Stockholm, Sweden, 171 76
- Karolinska University Hospital, Solna / Kirurgmottagningen
-
Uppsala, Sweden, 752 85
- Akademiska Hospital/ Kliniken f onkologisk endokrinologi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provision of written informed consent from the patient and their partner (if the partner will be administering the lanreotide Autogel injections during the self administration period)
- Male or female aged 18 years of age or older
- Treated with lanreotide Autogel 90 or 120 mg every 28th day for carcinoid symptoms on a stable dose for at least 3 months prior to inclusion. The patient is presumed to be clinically stable during the coming months
- Neuroendocrine tumour confirmed by biopsy and visible on radiology
Exclusion Criteria:
- Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
- Has a life expectancy less than a year, as judged by the Investigator
- The patient or their partner is not considered competent in injection technique, as judged by the Investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Preference for Self or Partner Administration
Time Frame: Between week 30 to 34
|
A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection
|
Between week 30 to 34
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Stating at Least One Injection Interfered With Daily Activities
Time Frame: Between baseline to week 32, after each injection (8-9 injections)
|
The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'
|
Between baseline to week 32, after each injection (8-9 injections)
|
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
Time Frame: Between baseline to week 32, after each injection (8-9 injections)
|
The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
|
Between baseline to week 32, after each injection (8-9 injections)
|
Days Sick Leave
Time Frame: Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)
|
Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).
|
Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)
|
Total Number of Visits to HCP Due to Carcinoid Symptoms
Time Frame: Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)
|
Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.
|
Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)
|
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Time Frame: Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).
|
Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection.
Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.
|
Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).
|
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Time Frame: Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).
|
Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection.
Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.
|
Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).
|
Chromogranin A Levels
Time Frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
|
Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects. 'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2. 'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2. 'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2. 'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2. |
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
|
5-hydroxyindoleacetic Acid (5-HIAA) Levels
Time Frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
|
Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site. 'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2. 'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2. 'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2. 'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2. |
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
|
Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
Time Frame: Between week 30 to 34
|
Assessed by the number of HCP with a positive response 'yes' to two questions:
|
Between week 30 to 34
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-99-52030-216
- 2007-006514-42 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuroendocrine Tumour With Carcinoid Symptoms
-
Advanced Accelerator ApplicationsCompletedCarcinoid Tumor of the Small Bowel | Neuroendocrine TumourUnited States, United Kingdom, Italy, Belgium, France, Germany, Portugal, Spain
-
Rutgers UniversityUnknownCarcinoid Neuroendocrine CancerUnited States
-
University of Western Ontario, CanadaCompletedNeuroendocrine Carcinoma (Carcinoid)Canada
-
Lytix Biopharma ASKarolinska University Hospital; Oslo University HospitalCompletedCancer With Transdermal Accessible TumourSweden, Norway
-
H. Lee Moffitt Cancer Center and Research InstituteNovartisTerminatedNeuroendocrine CarcinomaUnited States
-
Roswell Park Cancer InstituteNeuroEndocrine Tumor Research Foundation (NETRF)RecruitingLung Atypical Carcinoid Tumor | Metastatic Pancreatic Neuroendocrine Tumor | Lung Typical Carcinoid TumorUnited States
-
M.D. Anderson Cancer CenterRecruitingCarcinoid Tumor | Carcinoid Syndrome | Metastatic Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1United States
-
H. Lee Moffitt Cancer Center and Research InstitutePharmacyclics LLC.CompletedCarcinoid Tumors | Pancreatic NETUnited States
-
M.D. Anderson Cancer CenterWithdrawnCarcinoid Syndrome | Advanced Neuroendocrine Neoplasm
-
National Cancer Institute (NCI)CompletedMetastatic Gastrointestinal Carcinoid Tumor | Recurrent Gastrointestinal Carcinoid Tumor | Recurrent Islet Cell Carcinoma | Pulmonary Carcinoid TumorCanada
Clinical Trials on lanreotide (Autogel formulation)
-
IpsenCompleted
-
IpsenCompletedAcromegalyFrance, Switzerland
-
IpsenCompletedNon Functioning Entero-pancreatic Endocrine TumourUnited Kingdom, France, Spain, United States, Belgium, Czechia, Italy, Slovakia, Poland
-
IpsenCompleted
-
IpsenCompleted
-
IpsenTerminatedIntestinal ObstructionItaly
-
IpsenWithdrawn
-
IpsenCompletedAcromegalyUnited States, Germany, Hong Kong, Czechia, France, Hungary, Netherlands, United Kingdom
-
IpsenCompletedAcromegalyGermany, Netherlands, Sweden, Czechia, Denmark, France, Greece, Italy, Spain, United Kingdom
-
IpsenCompletedEndocrine TumorsUnited States, United Kingdom, Netherlands, Belgium, Sweden, Spain, France, Denmark, India, Germany, Austria, Czechia, Italy, Poland, Slovakia